Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
Arrow International, Inc. Reading, PA (6/3). Inspected 3/31-4/11. QSR deviations, adulterated: Company failed to identify the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems. For example, a nonconforming material report documented a manufacturing error used in the 7 Fr PTD catheters, but Arrow failed at the time to initiate a formal corrective action plan, including a complete evaluation of the root causes. Arrow also failed to have complete procedures for final acceptance activities, etc. (percutaneous thrombolytic catheters); FDCA 501(h), 21CFR 820.100(a)(3), 820.90(a), 820.70(a), 820.80(d) (05-NWJ-14)
http://www.fda.gov/foi/warning_letters/g5394d.pdf
Frankle, Mark A. Temple Terrace, FL (7/6). Inspected 2/22-3/30. Clinical investigator violations: Investigator implanted devices that did not have an FDA-approved IDE. During the inspection, Dr. Frankle said he believed the devices were custom devices, but FDA says they do not meet the definition of a custom device. Frankle also failed to adhere to the responsibilities of a clinical investigator such as ensuring the investigation is conducted according to the signed agreement, the investigational plan, and applicable FDA regulations, etc. (device study); FDCA 520(g), 21CFR 812.100 (No Code)
http://www.fda.gov/foi/warning_letters/g5397d.pdf
Greer Laboratories, Inc. Lenoir, NC (6/24). Inspected 2/14-3/3. GMP deviations: Lab failed to assure that the drug product meets the applicable standards of identity, strength, quality, purity, and potency at the time of use by appropriate stability testing. For example, the standardized Aqueous Short Ragweed Pollen Extracts Dilute using Coca’s Buffer were given an 18-month expiration date which is not supported because three lots of product failed to meet the 12-month potency test requirements. Greer continues to release the product with expiration dates exceeding 12 months. Greer also failed to report the potency stability failures to CBER. Final product vials were subjected to manipulations. For example, sterility test samples were collected from stoppered final product vials by removing the product from the vials with syringes. The vials from which samples were withdrawn were then released and distributed, etc. (drug products); FDCA 501(a)(2)(B), 21CFR 211.137(a), 211.166, 680.3(e), 610.10, 600.14, 211.113(b), 211.22, 211.192, 211.180(e), 211.42(c)(10)(iv)&(v), 600.11(a) (CBER-05-023)
http://www.fda.gov/foi/warning_letters/g5395d.pdf
Litron Laboratories Rochester, NY (7/1). Inspected 9/24-28. Violations: Firm failed to promptly record data generated during a non-clinical laboratory study and did not sign and date the data entries. The actual dose administered in the study is unknown. Firm did not record the time and collection and fixation of blood samples. After deaths of animals in the high dose levels in the preliminary dose range finding assay, the study director tested additional animals at the lowest and highest doses without documenting changes or revisions to the protocol and the reasons for the additional tests, etc. (non-clinical laboratory studies); 21CFR 58.130(e), 58.33(a), 58.120(a)&(b), 58.35(b), 58.90, 58.185(a) (05-HFD-45-0701)
http://www.fda.gov/foi/warning_letters/g5396d.pdf
Medical Science Products, Inc. Canal Fulton, OH (7/7). Inspected 6/7-10. QSR deviations, adulterated, misbranded: Company failed to establish procedures for implementing corrective and preventive actions. It sends replacement products to customers if they complain the electrodes are not sticking, but does not document this as a complaint or perform an investigation into the root cause of the problem. Incoming products are not always adequately inspected or tested to verify conformance to specifications, etc. (Class II disposable and re-usable electrodes); FDCA 501(h), 502(t)(2), 21CFR 820.100(a), 820.198, 820.184, 820.80, 820.90, 820.30, 820.20, 820.40, 803 (CIN-05-26433-14)
http://www.fda.gov/foi/warning_letters/g5401d.pdf
Mighell, Mark A. Temple Terrace, FL (7/6). Inspected 3/15-30. Clinical investigator deviations: Investigator failed to adhere to the general and specific responsibilities of an investigator. For example, six patients were implanted with (purged) components that were not components of (purged) between 7/26/04 and 1/17/05 and part of the approved study. Also an (purged) that did not have 510(k) clearance was implanted in a study subject. The device did not have an approved IDE at the time of implantation and was not part of the (purged). This makes the devices adulterated and misbranded, etc. (device study); FDCA 510(k), 502(o), 501(f)(1)(B), 21CFR 812.100, 812.100(c) (No Code)
http://www.fda.gov/foi/warning_letters/g5399d.pdf
Orthometrix, Inc. White Plains, NY Inspected 1/6-3/4. Clinical study violations: Firm failed to secure the investigators’ compliance with the investigational plan and applicable FDA regulations. A review of an inspection report for one of the clinical investigators participating in the study disclosed that violations were repeatedly committed at the site during the investigation, but there were no records to demonstrate that the firm obtained prompt correction and subsequent compliance by (purged), or that the firm was even aware of these violations, etc. (sponsor of device study); 21CFR 812.46(a), 812.40 (No Code)
